Clinical trial: intra dermal hepatitis B vaccination with topical imiquimod versus intra muscular hepatitis B vaccination in patients with inflammatory bowel disease. Issue 2 (11th May 2022)

• Record Type: Journal Article
• Authors: Ko, Kwan‐Lung; Lam, Yuk‐Fai; Cheung, Ka‐Shing; Hung, Ivan Fan‐Ngai; Leung, Wai K.
• Is Part Of: Alimentary pharmacology & therapeutics. Volume 56:Issue 2(2022)
• Page Start: 301
• Page End: 309
• Publication Date: 2022-05-11
• Subjects: Digestive organs -- Diseases -- Treatment -- Periodicals; Digestive organs -- Effect of drugs on -- Periodicals; Gastrointestinal system -- Diseases -- Treatment -- Periodicals; Gastrointestinal system -- Effect of drugs on -- Periodicals; 615.73
• DOI: 10.1111/apt.16970
• Languages: English
• ISSNs: 0269-2813

Abstract

Summary: Background: Efficacy with conventional intra muscular (IM) hepatitis B vaccination in patients with inflammatory bowel disease (IBD) is suboptimal. Aim: To compare the immunogenicity of intradermal (ID) hepatitis B vaccination after topical imiquimod pre‐treatment with IM hepatitis B vaccination in patients with IBD. Methods: Adult IBD patients with no evidence of hepatitis B infection or immunity (negative to HBsAg/anti‐HBc/anti‐HBs) were randomised 1:1 to receive either ID hepatitis B vaccine with topical imiquimod pre‐treatment to injection site (ID‐Imq) or IM hepatitis B vaccine with aqueous cream pre‐treatment (IM‐Aq) at 0, 1 and 6 months. Patients and investigators were blinded to the randomisation and intervention. The primary endpoint was seroprotection rate at 12‐month, defined as percentage of subjects with anti‐HBs ≥10 mIU/ml. Results: Between September 2019 and December 2020, 104 patients with IBD (68% male; 50% Crohn's) enrolled, and 53 assigned to ID‐Imq group. The percentage of patients using steroids, immunomodulators or biologics at randomisation was 15%, 55% or 22%, respectively. Seroprotection rate at 12 months was significantly higher in the ID‐Imq group than the IM‐Aq group (91% vs 69%; OR 4.39, 95% CI 1.47‐13.11). Multivariate analysis showed that ID vaccine with topical imiquimod and higher albumin level were associated with a higher seroprotection rate. The safety profile was similar but local reactions were more common in the ID‐Imq group. Conclusions: Intradermal hepatitis B vaccination with topical imiquimod pre‐treatment is safe and offers superior seroprotection to conventional IM administration in patients with IBD. Abstract : Eligible patients were randomised to receive ID vaccine with topical imiquimod or IM vaccine with topical aqueous cream. Seroprotection rate at 12‐month was 91% vs 69% ( p = 0.005). The geometric mean concentration of anti‐HBs of the two groups at different time points was shown in the lower panel.